Rigid protocols for embryo id safeguards patients against IVF lab mix-ups and brings peace of mind.
We are all concerned about mistakes in the IVF lab. Fortunately, those mistakes are exceedingly rare. Unfortunately, as we are all human, mistakes can happen. When they do, they get tremendous exposure in the media. The analogy that I tell my patients is that no one ever airs a story about the millions of airline passengers who travel safely across the United States every day – but we all sure hear more than we want to about the 150 who unfortunately died in a tragic accident.
Over 1.5 million IVF cycles have been performed in the last 10 years.
Similarly, when events like the one discussed on Dateline, it may help to put the subject in perspective. There are approximately 150,000 fresh IVF cycles performed just in the United States every year. If you consider the past 10 years alone, that’s approximately 1.5 million IVF cycles (not even including FET cycles). Yet over this time, there have been very few problems. While none of us has access to the exact number (as I suspect some are never publicized), the exact number is very small.
Regardless, even one mistake in this area is one too many. For this reason, I would like to tell you a little about the extraordinary lengths we go to at Texas Fertility Center and Austin IVF to ensure that we do everything possible to minimize the chance of our ever making a mistake involving an embryo.
Armbands are used to clearly identify TFC fertility patients during retrieval and transfer.
First of all, each patient receives a personalized arm band when she arrives at the St. David’s Fertility Center. This band contains all of your personalized identifying information although your doctor knows you well, the nurses, anesthesiologist, and embryologists have probably never met you. Therefore, although it may be frustrating, several different people will ask to look at your arm band and confirm that you are who you say you are. This will happen both at the time of your retrieval and at the time of your embryo transfer. It is possible that you may have the same nurse at both procedures, however she will check your arm band each time nevertheless. The anesthesiologist and your physician will also confirm your identity.
TFC takes a “Time-Out” for identification of both patient and embryo.
Before you are given anesthesia in the operating room, the embryologist will come into the room and also check your arm band. We will then do a “time out”, where the circulating nurse verbally states:
- your name
- your birthday
- any medication allergies that you have
- the surgeon’s name
- the type of procedure that will be performed
This information is confirmed by the circulating nurse, the scrub nurse, the anesthesiologist, the physician, and the embryologist. Only after that has been done – and all have agreed that the information is correct – is the retrieval performed.
All of Texas Fertility Center and Austin IVF’s staff are trained on embryo id safeguards.
Although we have 6 embryologists at Austin IVF, only one works on each patient’s case at a time. Therefore, once the eggs are removed, they are given to a specific embryologist who finds the eggs and places them into the appropriate dishes for culture. These dishes were made the night before your retrieval at that time, they were labeled with your name and your partner’s name.
After your eggs have been retrieved and you are back in the recovery area, one of the embryologists will come to see you. He or she will tell you how many eggs we retrieved. They will also confirm the identity of either your husband or the sperm donor (if you are using donor sperm) before we actually add any sperm to the dish containing your eggs. In fact, you and your husband will be asked to initial the actual laboratory form that we will use when we add the sperm to the eggs. This confirms each of your identities as well as our instructions about the sperm to use. We then add the sperm to the eggs five hours or so after the retrieval, and we then put the eggs back into the incubator overnight.
As you might imagine, our IVF laboratory is a very busy place. There are several different work stations strategically spaced in our IVF laboratory. However we have a very strict rule that only one patient’s gametes can be in each area at a time. If we need to evaluate several patients’ embryos on a given day (like we always have to do), each patient’s case must be completed and the gametes replaced into the incubator before the next patient’s embryos or gametes can be removed from the incubator.
As we have many incubators in the lab, each one has a label on the outside specifically stating the patient’s names whose gametes are in that incubator, as well as the exact location (shelf number) of those gametes within the incubator. Each patient’s identity is confirmed before and after the gametes are removed or returned to the incubator.
Visual identification of embryos, by closed-circuit video, is available to all Austin IVF patients before embryo transfer.
On the day of the embryo transfer, one of the embryologists will come to your room in the preoperative area to give you a digital picture of your embryos and discuss their progress with you. Before you go back to the operating room for the transfer, your identity will again be confirmed. This will happen again in the OR as part of the “time out” for that procedure. We will then ask you to watch the large monitor mounted on the back wall of the OR so that you can see live closed-circuit video coming directly from the IVF laboratory.
The embryologist preparing your embryos for transfer will show you your name for confirmation. They will then show you your embryo(s) before loading them into the transfer catheter. In this manner, we will have confirmed your identity, you will see the actual embryos that we are transferring,and you will confirm the actual number of embryos that we are transferring, and you will see them get loaded into the catheter.
The embryologist then brings the catheter into the OR, the transfer is performed, and they embryologist takes the catheter back into the lab. At that time, they will flush the catheter with fluid to confirm that every embryo was actually transferred and that none remain in the transfer catheter. If one failed to transfer, we will reload it and repeat the procedure (this is very rare and does not adversely affect your chance for pregnancy).
Passed with “Highest Quality”: Austin IVF is inspected regularly by CAP and the FDA.
All of our policies and procedures are recorded in a manual which is evaluated every 1-2 years when our laboratory is inspected by the College of American Pathologists (CAP). In addition to CAP inspection, we are subject to random inspections by inspectors from the Federal Food and Drug Administration (FDA). Our laboratory maintains the highest quality and several of our embryologists actually serve as CAP inspectors – inspecting other laboratories around the country.
As you can clearly see, we have spent a lot of time developing and refining our protocols and procedures in order to do all that we can do to minimize the likelihood that there would ever be a mistake in our laboratories. Although it may not be exciting to the media, the reality is that the odds of a mistake in a certified IVF laboratory in the United States are extremely low.